COSMEDIX SPF50- sunscreen emulsion

Cosmedix SPF50 by

Drug Labeling and Warnings

Cosmedix SPF50 by is a Otc medication manufactured, distributed, or labeled by Universal Packaging Systems, Inc. DBA: PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 5.0%

PURPOSE

Helps prevent sunburn

INSTRUCTIONS FOR USE

Apply liberally 15 minutes before sun exposure.

INACTIVE INGREDIENT

Water (Aqua), Propanediol, Dicaprylyl Carbonate, Carthamus Tinctorius (Safflower) Oleosomes, Cetyl Ethylhexanoate, Glycerin, Cetearyl Olivate, Squalane, Sorbitan Olivate, Silica, Trehalose, Trimethoxybenzylidene Pentanedione, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Tocopheryl Acetate, Ethylhexylglycerin, Citrus Grandis (Grapefruit) Peel Oil, Limonene, Potassium Sorbate, Polysorbate 60, Allantoin, Disodium EDTA, Titanium Dioxide (CI 77891), Caprylic/Capric Triglyceride, Sodium Hydroxide, Dimethyl Isosorbide, Carbomer, Moringa Pterygosperma Seed Extract, Boerhavia Diffusa Root Extract, Polysorbate 20, Sesamum Indicum (Sesame) Seed Extract, Urea, Glucosamine HCl, Algae Extract, Palmitoyl Oligopeptide, Tocopherol, Palmitoyl Tetrapeptide-7.

QUESTIONS

In the unlikely event of an adverse reaction, please contact 1-800-676-9522

WARNINGS

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.

INDICATIONS & USAGE

Helps protect against sunburn.

DOSAGE & ADMINISTRATION

Topical emulsion

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COSMEDIX SPF50 
sunscreen emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61531-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.05 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61531-103-01	50 g in 1 TUBE; Type 0: Not a Combination Product	11/24/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/24/2015

Labeler - Universal Packaging Systems, Inc. DBA: PakLab (790530976)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc. DBA: PakLab		790530976	MANUFACTURE(61531-103)